At a glance
ClinicalIndex Comparison Record- ✓Healthy pregnant females, 30–36 weeks gestation
- ✓Age 18–45 years inclusive
- ✓Symptoms of preterm labor: ≥6 uterine contractions per hour (each ≥30 sec duration) with cervical dilation ≤4 cm
- ✕Ruptured membranes
- ✕Clinically relevant abnormality on screening or any medical condition making mother and/or fetus unsuitable for participation
- ✕Pre-existing or pregnancy-related comorbidities affecting maternal or neonatal outcome (e.g., hypertension, diabetes mellitus, bleeding/clotting disorder)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK221149A Administered Intravenously and to Investigate the Pharmacokinetics of GSK221149A Administered Orally to Healthy, Pregnant Females With Uncomplicated Pre-term Labor Between 300/7 and 356/7 Weeks' Gestation
In Brief
A Phase 2 clinical trial evaluating GSK221149A and Placebo for Obstetric Labour, Premature. Completed, enrolled 93 participants across 57 sites in 11 countries.
Detailed Summary
Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149A is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, patients with preterm labor will be given an intravenous infusion of GSK221149A over approximately 12 hours followed by an oral tablet in Parts A and B. In part C of this study, patients with preterm labor will be give an intravenous infusion of GSK221149A over approximately 48 hours. The use of a rescue tocolytic is allowed in the study.
Study Details
Timeline
Interventions
6mg/h and 12 mg/h
Matched Placebo to Drug